Perioperative Lidocaine in Enhanced Recovery After Major Non-Cardiac Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, pragmatic, randomized, blinded, placebo-controlled trial assessing the effect of perioperative intravenous lidocaine within an ERAS pathway on outcomes after major non-cardiac surgery. Participants receive lidocaine HCl 0.8% in D5W as part of multimodal pain management. The study compares hospital length of stay adjusted for patient mix, inpatient opioid use, pain levels, return of bowel function, nausea, infections, ICU transfers, and other surgical outcomes, while monitoring for adverse effects. Eligible patients are adults (18+) undergoing major elective non-cardiac surgery in specified specialties, with ASA I–IV; several contraindications apply. The primary sponsor is Vanderbilt University Medical Center.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Age greater than or equal to 18
* American Society of Anesthesiologists (ASA) class I-IV
* Presenting for major elective, non-cardiac surgery on the colorectal, emergency general surgery, urology, ventral hernia, surgical oncology, or spine services on a weekday
* First surgery in the study period (if a patient has multiple surgeries, only the first will be included)

Exclusion criteria:

* ASA class \>IV
* Emergent procedures
* Allergy or any contraindication to lidocaine infusion
* Patient refusal
* Unable to receive or refusal to receive a regional nerve block
* Patients who receive an epidural due to standard of care
* Direct transfer from operating room to ICU with endotracheal tube in place
* Treating team determines patient ineligible prior to study drug administration
* Same day surgery
* Pregnancy (all female patient of child-bearing age will undergo a pregnancy test the day of surgery)

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Danial Shams, MD — Vanderbilt University Medical Center
• Study coordinator: Danial Shams, MD
• Email: danial.shams@vumc.org
• Phone: 615-936-3198

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.